FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
128161–128184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 1989
LATEX PATIENT EXAMINATION GLOVES
K894999 · LYY
Pushpaman Processors, Div. Kanjur...
General Hospital · 112d
Cleared Nov 28, 1989
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
K895149 · CCE
Shiley, Inc.
Anesthesiology · 97d
Cleared Nov 28, 1989
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
K895150 · CCE
Shiley, Inc.
Anesthesiology · 97d
Cleared Nov 28, 1989
ABBOTT INPERSOL CYCLER 1000
K895336 · FKX
Abbott Laboratories
Gastroenterology & Urology · 89d
Cleared Nov 28, 1989
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20
K895428 · DXN
A&D Engineering, Inc.
Cardiovascular · 84d
Cleared Nov 28, 1989
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650
K895429 · DXN
A&D Engineering, Inc.
Cardiovascular · 84d
Cleared Nov 28, 1989
HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100
K895430 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 84d
Cleared Nov 28, 1989
STANDARD CONDOM
K895530 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 76d
Cleared Nov 28, 1989
LONE STAR TRADING SURGICAL GLOVE
K896051 · KGO
Lone Star Trading Pte. , Ltd.
General Hospital · 41d
Cleared Nov 28, 1989
BIOBRANE(R) II
K896110 · KGN
Sterling Drug, Inc.
General & Plastic Surgery · 36d
Cleared Nov 28, 1989
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717
K896392 · CAZ
Medtronic Vascular
Anesthesiology · 22d
Cleared Nov 27, 1989
LATEX EXAMINATION GLOVES
K893366 · LYY
Jinshan Caojing Latex Factory
General Hospital · 216d
Cleared Nov 27, 1989
DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
K893678 · KRH
Medtronic Blood Systems, Inc.
Cardiovascular · 195d
Cleared Nov 27, 1989
TENZCARE ELECTRODE 6862
K893793 · GXY
3M Company
Neurology · 189d
Cleared Nov 27, 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
K894168 · DQO
Baxter Healthcare Corp
Cardiovascular · 165d
Cleared Nov 27, 1989
NEW FREEDOM ANYDAY PANTILINERS
K894229 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 161d
Cleared Nov 27, 1989
MULTISPIRO
K895375 · BZG
Medical Equipment Designs, Inc.
Anesthesiology · 89d
Cleared Nov 27, 1989
REMINGTON TANFASTIC HANDHELD TANNING WAND
K895410 · FTC
Remington Products Company, LLC
General & Plastic Surgery · 82d
Cleared Nov 27, 1989
CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)
K895446 · HDB
Challenge Mfg., Inc.
Obstetrics & Gynecology · 80d
Cleared Nov 27, 1989
LATEX PATIENT EXAMINATION GLOVES
K895491 · LYY
Big Rubber Co., Ltd.
General Hospital · 95d
Cleared Nov 27, 1989
D.L. SCOPE OPHTHALMOSCOPE
K896072 · HLJ
North American Medical Products, Inc.
Ophthalmic · 39d
Cleared Nov 27, 1989
RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE
K896119 · IXR
Rms Div.
Radiology · 34d
Cleared Nov 27, 1989
NEEDLE SYRINGE DISPOSAL DEVICE
K896195 · MMK
Advanced Medical Components, Inc.
General Hospital · 33d
Cleared Nov 27, 1989
MODIFIED AXOSTIM
K896368 · BXN
Singer Medical Products, Inc.
Anesthesiology · 21d